The trial of Umifenovir on 132 Covid-19 sufferers confirmed that, if correct dose is given twice each day for 5 days, the drug can successfully cut back viral load to zero in gentle or average symptomatic and asymptomatic sufferers by checking multiplication of the virus.
Titled ‘Phase III, randomized, double-blind, placebo controlled trial of efficacy, safety and tolerability of antiviral drug Umifenovir vs standard care of therapy in non-severe Covid-19 patients’, the scientific trial was performed at three establishments – KGMU, Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and Era’s Lucknow Medical College and Hospital (ELMCH).
“Since Umifenovir is a broad spectrum antiviral and is being used as a safe over-the-counter drug for influenza and pneumonia for over 20 years in Russia, China and other countries, the first two trials were not mandatory,” CDRI director Prof Tapas Kundu stated.
“CDRI, therefore, directly went for phase-III trial, which was conducted on 132 patients who were either admitted to hospitals or were in home quarantine under the supervision of these hospitals,” CDRI director Prof Tapas Kundu stated.
“In a study, double-blind mode improves reliability of results by preventing bias when doctors evaluate patients’ outcomes. The results showed that viral load in mild, moderate or asymptomatic patients after being given two doses of Umifenovir (800mg) twice a day, became zero in an average of five days. Patients did not experience any side-effects and their symptoms also did not turn severe,” he stated.
“Studies by CDRI in collaboration with CSIR-IMT, Chandigarh, also showed that Umifenovir exhibits good cell culture inhibition of SARS-Cov2, which suggests that the drug inhibits the entry of SARS-Cov2 virus into human cells,” Prof Kundu stated.
He stated the institute was getting the dosage plan patented because it had not been used earlier for Covid-19.
“The Drug Controller General of India (DCGI) has evaluated the clinical trials report and in view of the highly encouraging results, he has asked the team to continue the studies on more mild, asymptomatic patients for grant of emergency approval of the drug,” he added.
Chief scientist, CDRI, Prof R Ravishankar, who led the workforce of scientists, stated: “Umifenovir will be economical for treating Covid-19 patients as it is around 50-54% cheaper as compared to current medication. Expert from the three hospitals which were part of the study said the drug is safe for pregnant women and children. We are looking into the possibility of Umifenovir syrup for children and also in powder form so that it can be used as puff inhalers.”
According to CDRI, the top of KGMU’s medication division, Dr Virendra Atam, and medical superintendent, Dr Himanshu Reddy, who had been principal investigators of the research on the college, talked about in their report carried out for the research that quicker restoration of coronavirus sufferers would cut back virus shedding and consequent unfold of an infection to others.
It additionally stated that the principal of Era’s Medical College, Prof MMA Faridi, talked about in his report that Umifenovir might be prescribed to pregnant girls and youngsters, if permitted by the authorities.
Similarly, Prof Vikram Singh from RMLIMS prompt that as Umifenovir was secure, it had important efficacy on gentle and asymptomatic sufferers and may be helpful as a prophylactic for top-threat sufferers.
CDRI spokesperson Sanjeev Yadav stated, “Umifenovir was selected from 16 drugs suggested by the CSIR after looking into the feasibility of synthesis using locally available chemicals at the peak of pandemic. The DCGI then gave permission for trials in June last year.”
A workforce of CDRI chemists, Ajay Okay Srivastava, Chandra Bhushan Tripathi, Nayan Ghosh and Nilanjana Majumdar, and their college students, synthesized the drug and developed the method know-how – chemical processing used to refine uncooked materials into completed product – in document time.
The know-how was then transferred to a Goa-based non-public pharmaceutical firm inside a month’s time to make the “active pharmaceutical ingredient” (API) and tablets for trials.
Finally, after securing moral approvals and finishing stability research of the drug at CDRI, the workforce of researchers took consent of sufferers and roped them in for the research.
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